An Open-Label Pilot Study to Evaluate the Effectiveness and Tolerability of a Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Cutaneous Symptom Relief
研究概览
简要总结
The purpose of this study is to determine the effectiveness and tolerability of a novel topical preparation for the treatment of cutaneous lesions of mastocytosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven cutaneous mastocytosis with or without evidence of systemic disease
- •Male and female patients 18 to 80 years of age
- •No UVB treatment of the skin for 6 months prior to study entry
- •No use of topical or systemic corticosteroids for 1 month prior to study entry
- •Good general health as confirmed by medical history
- •Female patients of child-bearing potential with negative urine pregnancy test who agree to use effective methods of birth control or remain abstinent during treatment. Participants must use birth control for the entire study and for at least 1 week after the last application of the study formulation. Acceptable methods of birth control include ongoing hormonal contraception methods, (such as birth control pills, patches, injections, vaginal ring, or implants), barrier methods (such as a condom (for men) or diaphragm used with a spermicide), intrauterine devices, tubal ligation, or abstinence.
- •Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
- •Patients who read and sign an approved informed consent for this study
排除标准
- •Vulnerable study population
- •Exposure to ultraviolet B (UVB) radiation to any region of the skin surface for 6 months
- •Regular use of skin lightening agents within 1 month of study entry, including
- •Topical corticosteroids
- •Topical bleaching products
- •Topical retinoids
- •Use of systemic preparations within 1 month of study entry, including:
- •Systemic corticosteroids
- •Systemic cyclosporine, interferon
- •Systemic acitretin, etretinate, isotretinoin
- •Systemic methotrexate,
- •Systemic photoallergic, phototoxic and/or photosensitizing drugs
- •UV light therapy and sunbathing
- •Inability to communicate or cooperate with the Principal Investigator and/or Investigators due to language problems, poor mental development or impaired cerebral function
- •Pregnant or nursing women
- •Women planning a pregnancy within the study period
研究组 & 干预措施
Skin Guard
Skin cream combination of ingredients includes 2 agents which target mast cell mediators and one agent which globally reduces mast cell degranulation combined in an emollient cream base:
Vanicream: Over the counter emollient cream Diphenhydramine Antihistamine Trolamine salicylate Prostaglandin inhibitor, antiinflammatory Cromolyn Sodium Mast cell degranulation inhibitor
干预措施: Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base. (Combination Product)
结局指标
主要结局
Cutaneous Symptom Relief
时间窗: 2 weeks
Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin
SkinDex-16 Quality of Life Questionnaire
时间窗: 2 weeks
This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.
SkinDex-16 Quality of Life Questionnaire
时间窗: Baseline
This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.
次要结局
未报告次要终点
研究者
Joseph Butterfield
Principal Investigator
Mayo Clinic